Trials / Completed
CompletedNCT00734578
Efficacy and Safety of SPD503 in Combination With Psychostimulants
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 461 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD503-AM | SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg |
| DRUG | SPD503-PM | SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg |
| DRUG | Placebo | Placebo matched to Guanfacine Hydrochloride Extended Release |
Timeline
- Start date
- 2008-09-02
- Primary completion
- 2009-12-10
- Completion
- 2009-12-10
- First posted
- 2008-08-14
- Last updated
- 2021-06-14
- Results posted
- 2010-11-23
Locations
61 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00734578. Inclusion in this directory is not an endorsement.